目的 探讨安胎益母丸联合地屈孕酮片治疗早期先兆流产的临床疗效。方法 选取2021年4月—2023年4月在青岛市城阳区人民医院进行保胎治疗并定期产检的早期先兆流产孕妇99例，根据治疗方案分成对照组（49例）和治疗组（50例）。对照组口服地屈孕酮片，首次剂量为40 mg，后续3次/d，10 mg/次；治疗组在对照组的基础上口服安胎益母丸，1丸/次，2次/d。两组孕妇均进行2周治疗。观察两组患者临床疗效，比较治疗前后两组患者中医证候评分，血清同型半胱氨酸（Hcy）、妊娠相关血浆蛋白A（PAPP-A）、α-黑色素细胞刺激素（α-MSH）和糖类抗原125（CA125）水平，及血清Th1/Th2细胞因子水平。结果 治疗后，对照组和治疗组临床总有效率分别为79.59%和94.00%，组间比较差异具有统计学意义（P＜0.05）。治疗后，两组患者中医证候评分均明显降低（P＜0.05），且治疗组中医证候评分降低更明显（P＜0.05）。治疗后，两组血清Hcy、α-MSH和CA125水平均明显降低，而PAPP-A水平则明显升高（P＜0.05），且治疗组各指标改善更明显（P＜0.05）。治疗后，两组血清Th1细胞因子肿瘤坏死因子-α（THF-α）和白细胞介素-2（IL-2）均明显降低，而Th2细胞因子白细胞介素-4（IL-4）和白细胞介素-10（IL-10）则明显升高（P＜0.05），且治疗组改善更为明显（P＜0.05）。结论 安胎益母丸联合地屈孕酮治疗早期先兆流产疗效显著，不仅能够显著改善孕妇不适症状和促进血清学指标的恢复，同时还能够改善免疫功能失衡状态。

Objective To investigate the clinical effectiveness of Antai Yimu Pills combined with Dydrogesterone Tablets in treatment of early threatened miscarriage. Methods Patients (99 cases) with early threatened miscarriage in Qingdao Chengyang People's Hospital from April 2021 to April 2023 were divided into control (49 cases) and treatment (50 cases) group based on different treatments. Patients in the control group were po administered with Dydrogesterone Tablets, the first dose was 40 mg, followed by three times daily for with 10 mg/time. Patients in the treatment group were po administered with Antai Yimu Pills on the basis of the control group, 1 pill/time, twice daily. Patients in two groups were treated for 2 weeks. After treatment, the clinical evaluations were evaluated, the TCM syndrome scores, the levels of serum Hcy, PAPP-A, α-MSH and CA125, and the serum Th1/Th2 cytokine levels in two groups before and after treatment were compared. Results After treatment, the total clinical effective rate of the control group and the treatment group was 79.59% and 94.00% respectively, and the difference between two groups was statistically significant (P < 0.05). After treatment, the TCM syndrome scores in two groups were significantly decreased (P < 0.05), and the TCM syndrome scores in the treatment group were decreased more significantly (P< 0.05). After treatment, the levels of serum Hcy,α-MSH and CA125 were significantly decreased, while the level of PAPP-A was significantly increased in two groups, the improvement of all indexes in the treatment group was more obvious (P < 0.05). After treatment, serum Th1 cytokines THF-α and IL-2 were significantly decreased, while Th2 cytokines IL-4 and IL-10 were significantly increased in two groups, and the improvement in the treatment group was more obvious (P < 0.05). Conclusion Antai Yimu Pills combined with ditroprogesterone is effective in treatment of early threatened abortion, which can not only significantly improve the symptoms of pregnant women and promote the recovery of serological indexes, but also improve the imbalance of immune function.

R984

青岛市医药卫生科研指导项目（2022-WJZD239）